I 

114TH CONGRESS 

1ST SESSION H. R. 971 

To amend the Federal Food, Drug, and Cosmetic Act to authorize a 6- 

month extension of certain exclusivity periods in the case of approved 

drugs that are subsequently approved for a new indication to prevent, 

diagnose, or treat a rare disease or condition, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 13, 2015 

Mr. BILIRAKIS (for himself, Mr. MCCAUL, and Mr. BUTTERFIELD) introduced 

the following bill; which was referred to the Committee on Energy and 

Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

authorize a 6-month extension of certain exclusivity periods in the case of approved drugs that are subsequently 

approved for a new indication to prevent, diagnose, or 

treat a rare disease or condition, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Orphan Product Ex5 tensions Now Accelerating Cures and Treatments Act of 

6 2015’’. 


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1 SEC. 2. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG 

2 APPROVED FOR A NEW INDICATION FOR A 

3 RARE DISEASE OR CONDITION. 

4 (a) IN GENERAL.—Chapter V of the Federal Food, 

5 Drug, and Cosmetic Act is amended by inserting after sec6 tion 505E of such Act (21 U.S.C. 355f) the following: 

7 ‘‘SEC. 505F. EXTENSION OF EXCLUSIVITY PERIODS FOR A 

8 DRUG APPROVED FOR A NEW INDICATION 

9 FOR A RARE DISEASE OR CONDITION. 

10 ‘‘(a) DESIGNATION.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall des12 ignate a drug as a drug approved for a new indica13 tion to prevent, diagnose, or treat a rare disease or 

14 condition for purposes of granting the extensions 

15 under subsection (b) if— 

16 ‘‘(A) prior to approval of an application or 

17 supplemental application for the new indication, 

18 the drug was approved or licensed for mar19 keting under section 505(c) of this Act or sec20 tion 351(a) of the Public Health Service Act, 

21 but was not so approved or licensed for the new 

22 indication; 

23 ‘‘(B) the sponsor of the approved or li24 censed drug files an application or a supple25 mental application for approval of the new indiVerDate Sep 11 2014 02:43 Feb 26, 2015 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H971.IH H971

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1 cation for use of the drug to prevent, diagnose, 

2 or treat the rare disease or condition; 

3 ‘‘(C) the application or supplemental appli4 cation for the new indication contains— 

5 ‘‘(i) a request for designation of the 

6 drug under this section; 

7 ‘‘(ii) the consent of the applicant to 

8 notice being given by the Secretary under 

9 paragraph (4) respecting the designation 

10 of the drug; and 

11 ‘‘(iii) in the case of a drug for which 

12 an extension is sought under subsection 

13 (b)(3), a list specifying each patent— 

14 ‘‘(I) which claims the drug or a 

15 method of using the drug; and 

16 ‘‘(II) with respect to which a 

17 claim of patent infringement could 

18 reasonably be asserted if a person not 

19 licensed by the owner engaged in the 

20 manufacture, use, or sale of the drug; 

21 and 

22 ‘‘(D) the Secretary approves the applica23 tion or supplemental application. 

24 ‘‘(2) REVOCATION OF DESIGNATION.— 


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1 ‘‘(A) IN GENERAL.—Except as provided in 

2 subparagraph (B), a designation under this 

3 subsection shall not be revoked for any reason. 

4 ‘‘(B) EXCEPTION.—The Secretary may re5 voke a designation of a drug under paragraph 

6 (1) if the Secretary finds that the application or 

7 supplemental application resulting in such des8 ignation contained an untrue statement of ma9 terial fact. 

10 ‘‘(3) NOTIFICATION PRIOR TO DISCONTINUANCE

11 OF PRODUCTION FOR SOLELY COMMERCIAL REA12 SONS.—A designation of a drug under paragraph (1) 

13 shall be subject to the condition that the sponsor of 

14 the drug will notify the Secretary of any discontinu15 ance of the production of the drug for solely com16 mercial reasons at least one year before such dis17 continuance. 

18 ‘‘(4) NOTICE TO PUBLIC.—Notice respecting 

19 the designation of a drug under paragraph (1)— 

20 ‘‘(A) shall be made available to the public; 

21 and 

22 ‘‘(B) shall include any listing of patents 

23 under subsection (a)(1)(C)(iii). 


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1 ‘‘(b) EXTENSION.—If the Secretary designates a 

2 drug as a drug approved for a new indication for a rare 

3 disease or condition, as described in subsection (a)(1)— 

‘‘(1)(A)(i) the 4-, 5-, and 71 4 ⁄2-year periods de5 scribed in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) 

6 of section 505, and the 3-year periods described in 

7 clauses (iii) and (iv) of subsection (c)(3)(E) and 

8 clauses (iii) and (iv) of subsection (j)(5)(F) of sec9 tion 505, as applicable, shall be extended by 6 

10 months; or 

11 ‘‘(ii) the 4- and 12-year periods described in 

12 subparagraphs (A) and (B) of section 351(k)(7) of 

13 the Public Health Service Act, as applicable, shall be 

14 extended by 6 months; and 

15 ‘‘(B) the 7-year period described in section 527, 

16 as applicable, shall be extended by 6 months; 

17 ‘‘(2) if, at the time a drug is designated under 

18 subsection (a)(1)— 

19 ‘‘(A) the drug is the subject of a listed pat20 ent for which a certification has been submitted 

21 under subsection (b)(2)(A)(ii) or 

22 (j)(2)(A)(vii)(II) of section 505 or a listed pat23 ent for which a certification has been submitted 

24 under subsections (b)(2)(A)(iii) or 

25 (j)(2)(A)(vii)(III) of section 505, the period 


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1 during which an application may not be ap2 proved under section 505(c)(3) or section 

3 505(j)(5)(B) shall be extended by a period of 6 

4 months after the date the patent expires (in5 cluding any patent extensions); or 

6 ‘‘(B) the drug is the subject of a listed 

7 patent for which a certification has been sub8 mitted under subsection (b)(2)(A)(iv) or 

9 (j)(2)(A)(vii)(IV) of section 505, and in the pat10 ent infringement litigation resulting from the 

11 certification the court determines that the pat12 ent is valid and would be infringed, the period 

13 during which an application may not be ap14 proved under section 505(c)(3) or section 

15 505(j)(5)(B) shall be extended by a period of 6 

16 months after the date the patent expires (in17 cluding any patent extensions); and 

18 ‘‘(3) if the drug is a biological product, the Sec19 retary shall not grant final effective approval for any 

20 application submitted under section 351(k)(1) of the 

21 Public Health Service Act for a biosimilar biological 

22 product that cites such drug as its reference product 

23 until the date that is 6 months after the expiration 

24 of every patent that, as of the date on which the 

25 drug is designated under subsection (a)(1), is listed 


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1 for such drug pursuant to subsection (a)(1)(C)(iii), 

2 except that, if a court from which no appeal (other 

3 than a writ of certiorari) has been or could be taken 

4 rules a listed patent invalid or not infringed, then 

5 such patent shall no longer be considered for pur6 poses of this paragraph. 

7 ‘‘(c) RELATION TO PEDIATRIC AND QUALIFIED IN8 FECTIOUS DISEASE PRODUCT EXCLUSIVITY.—Any exten9 sion under subsection (b) of a period shall be in addition 

10 to any extension of the periods under sections 505A and 

11 505E of this Act and section 351(m) of the Public Health 

12 Service Act, as applicable, with respect to the drug. 

13 ‘‘(d) LIMITATIONS.—The extension described in sub14 section (b) shall not apply if the drug designated under 

15 subsection (a)(1) has previously received an extension by 

16 operation of subsection (b). 

17 ‘‘(e) REGULATIONS.— 

18 ‘‘(1) IN GENERAL.—Not later than 2 years 

19 after the date of enactment of this section, the Sec20 retary shall adopt final regulations implementing 

21 this section. 

22 ‘‘(2) PROCEDURE.—In promulgating a regula23 tion implementing this section, the Secretary shall— 

24 ‘‘(A) issue a notice of proposed rulemaking 

25 that includes the proposed regulation; 


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1 ‘‘(B) provide a period of not less than 60 

2 days for comments on the proposed regulation; 

3 and 

4 ‘‘(C) publish the final regulation not less 

5 than 30 days before the effective date of the 

6 regulation. 

7 ‘‘(3) RESTRICTIONS.—Notwithstanding any 

8 other provision of law, the Secretary shall promul9 gate regulations implementing this section only as 

10 described in paragraph (2), except that the Sec11 retary may issue interim guidance for sponsors seek12 ing to submit an application or supplemental appli13 cation described in subsection (a) prior to the pro14 mulgation of such regulations. 

15 ‘‘(4) DESIGNATION PRIOR TO REGULATIONS.— 

16 The Secretary shall designate drugs under sub17 section (a) prior to the promulgation of regulations 

18 under this subsection, if such drugs meet the criteria 

19 described in subsection (a). 

20 ‘‘(f) DEFINITION.—In this section: 

21 ‘‘(1) The terms ‘biological product’, ‘biosimilar’, 

22 and ‘reference product’ have the meanings given to 

23 such terms in section 351(i) of the Public Health 

24 Service Act. 


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1 ‘‘(2) The term ‘rare disease or condition’ has 

2 the meaning given to such term in section 

3 526(a)(2).’’. 

4 (b) APPLICATION.—Section 505F of the Federal 

5 Food, Drug, and Cosmetic Act, as added by subsection 

6 (a), applies only with respect to a drug for which an appli7 cation or supplemental application described in subpara8 graphs (B) and (C) of subsection (a)(1) of such section 

9 505F is first approved under section 505(c) of such Act 

10 (21 U.S.C. 355(c)) or section 351(a) of the Public Health 

11 Service Act (42 U.S.C. 262(a)) on or after the date of 

12 the enactment of this Act. 

13 (c) CONFORMING AMENDMENTS.— 

14 (1) RELATION TO PEDIATRIC EXCLUSIVITY FOR

15 DRUGS.—Section 505A of the Federal Food, Drug, 

16 and Cosmetic Act (21 U.S.C. 355a) is amended— 

17 (A) in subsection (b), by adding at the end 

18 the following: 

19 ‘‘(3) RELATION TO EXCLUSIVITY FOR A DRUG

20 APPROVED FOR A NEW INDICATION FOR A RARE DIS21 EASE OR CONDITION.—Notwithstanding the ref22 erences in subsection (b)(1) to the lengths of the ex23 clusivity periods after application of pediatric exclu24 sivity, the 6-month extensions described in subVerDate Sep 11 2014 02:43 Feb 26, 2015 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H971.IH H971

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1 section (b)(1) shall be in addition to any extensions 

2 under section 505F.’’; and 

3 (B) in subsection (c), by adding at the end 

4 the following: 

5 ‘‘(3) RELATION TO EXCLUSIVITY FOR A DRUG

6 APPROVED FOR A NEW INDICATION FOR A RARE DIS7 EASE OR CONDITION.—Notwithstanding the ref8 erences in subsection (c)(1) to the lengths of the ex9 clusivity periods after application of pediatric exclu10 sivity, the 6-month extensions described in sub11 section (c)(1) shall be in addition to any extensions 

12 under section 505F.’’. 

13 (2) RELATION TO EXCLUSIVITY FOR NEW

14 QUALIFIED INFECTIOUS DISEASE PRODUCTS THAT

15 ARE DRUGS.—Subsection (b) of section 505E of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 355f) is amended— 

18 (A) by amending the subsection heading to 

19 read as follows: ‘‘RELATION TO PEDIATRIC EX20 CLUSIVITY AND EXCLUSIVITY FOR A DRUG AP21 PROVED FOR A NEW INDICATION FOR A RARE

22 DISEASE OR CONDITION’’; and 

23 (B) by striking ‘‘any extension of the pe24 riod under section 505A’’ and inserting ‘‘any 


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1 extension of the periods under sections 505A or 

2 505F’’. 

3 (3) RELATION TO PEDIATRIC EXCLUSIVITY FOR

4 BIOLOGICAL PRODUCTS.—Section 351(m) of the 

5 Public Health Service Act (42 U.S.C. 262(m)) is 

6 amended by adding at the end the following: 

7 ‘‘(5) RELATION TO EXCLUSIVITY FOR A BIO8 LOGICAL PRODUCT APPROVED FOR A NEW INDICA9 TION FOR A RARE DISEASE OR CONDITION.—Not10 withstanding the references in paragraphs (2)(A), 

11 (2)(B), (3)(A), and (3)(B) to the lengths of the ex12 clusivity periods after application of pediatric exclu13 sivity, the 6-month extensions described in such 

14 paragraphs shall be in addition to any extensions 

15 under section 505F.’’. 

Æ 


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